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Completed

NCT Number: NCT05343858

Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome

The purpose of this study is to evaluate the effect of the consumption of two microalgae Chlorella vulgaris and Arthrospira platensis (Spirulina) on some biomarkers of metabolic syndrome: Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, Apolipoprotein A and Apolipoprotein B, in overweight / obese subjects with altered lipid profile.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

About this study

A randomized, parallel, and double-blind pilot study with 3 study arms is being performed to evaluate the effect of the consumption of two unicellular microalgae: Chlorella vulgaris and Arthrospira platensis (Spirulina).

The investigators included 30 participants between 18 and 65 years (BMI ≥25 and <40 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products during 30 days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women from 18 to 65 years old.
  • Body Mass Index (BMI) ≥25 and <40 kg/m2.
  • Cardiovascular risk <10%
  • Adequate cultural level and understanding
  • Agree to participate in the study

Exclusion criteria

  • Subjects with BMI ≥40 or <25 kg /m2
  • Subjects diagnosed with Diabetes Mellitus.
  • Subjects with dyslipidemia on pharmacological treatment
  • Subjects with hypertension on pharmacological treatment
  • Subjects with established diagnosis of eating disorder
  • Smokers or those subjects with high alcohol consumption
  • Subjects under pharmacological treatment
  • Subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet
  • Subjects with sensory problems
  • Subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients
  • Pregnant or breastfeeding women
  • Women with menstrual irregularities
  • Subjects with intense physical activity
  • Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
  • Subjects with a diagnosis of celiac disease or a gluten intolerance

Treatment and study plan

Experimental: Group 1: Spirulina platensis

Dietary Supplement

16 g/day (two doses of 8g)

Experimental: Group 2: Chlorella vulgaris

Dietary Supplement

16 g/day (two doses of 8g)

Placebo Comparator: Group 3: Control

Dietary Supplement

16 g/day (two doses of 8g)

Primary outcomes

  1. Serum cholesterol

    Time frame: Change from baseline at 30 days

    Biomarker of metabolic syndrome

  2. Serum HDL

    Time frame: Change from baseline at 30 days

    Biomarker of lipid profile quality

  3. Serum LDL syndrome biomarker

    Time frame: Change from baseline at 30 days

    Biomarker of lipid profile quality

  4. Triglycerides (TAG)

    Time frame: Change from baseline at 30 days

    Biomarker of lipid profile quality

  5. Apolipoprotein A

    Time frame: Change from baseline at 30 days

    Metabolic syndrome biomarker

  6. Apolipoprotein B

    Time frame: Change from baseline at 30 days

    Metabolic syndrome biomarker

Secondary outcomes

  1. Blood count

    Time frame: Change from baseline at 30 days

    Concentration of blood

  2. Body weight

    Time frame: Change from baseline at 30 days

    Changes on anthropometric characteristics

  3. Tolerance

    Time frame: Change from baseline at 30 days

    Occurrence and frequency of gastrointestinal symptoms

  4. Body Mass Index

    Time frame: Change from baseline at 30 days

    Changes on anthropometric characteristics

  5. Waist circumference

    Time frame: Change from baseline at 30 days

    Changes on anthropometric characteristics

  6. Adherence

    Time frame: Change from baseline at 30 days

    Changes in the number of consumed pills

  7. Sensory perception Visual Analog Scale (VAS) rate from 1 to 100 related with flavor, aro

    Time frame: Change from baseline at 30 days

    Visual Analog Scales (VAS) with a range between 0 (negative score) and 10 (positive score) related to taste, smell, texture, satiety and fullness

  8. Dietary intake

    Time frame: Change from baseline at 30 days

    Changes in diet composition through 24-hour dietary record

  9. Glucose

    Time frame: Change from baseline at 30 days

    Concentration of glucose

  10. Urate

    Time frame: Change from baseline at 30 days

    Concentration of safety marker

  11. Creatinine

    Time frame: Change from baseline at 30 days

    Concentration of creatinine

  12. Calcium

    Time frame: Change from baseline at 30 days

    Concentration of minerals

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Collaborators

  • AlgaEnergy, S.A.

Registry information

Official study title

Pilot Study to Evaluate the Effect of the Consumption of Two Unicellular Microalgae (Chlorella Vulgaris and Arthrospira Platensis (Spirulina)) on Metabolic Syndrome Biomarkers in Overweight / Obese Subjects With Altered Lipid Profile

Acronym: ALGAENERGY

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Apr 25, 2022
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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